CompletedPhase 4

Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study

China770 participantsStarted 2017-09-01

Plain-language summary

This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical rational drug use.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients meeting International Classification of Diseases (tenth version, ICD-10) criteria for schizophrenia. * acute episode; inpatients * Age from 18-65 years old (inclusion), male or female * PANSS total score at least 70 * scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ; and PANSS positive score is higher than PANSS negative score * Written informed consent Exclusion Criteria: * other serious diseases; * Pregnant or breast feeding women or planning a pregnancy * Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side effect, or with a history of malignant syndrome or serious extrapyramidal side effect; * Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * Allergy to Aripiprazole * History of alcohol or drug abuse or dependence in the past 1-year before screening * mental retardation; bipolar disorder; major depressive disorder; * Currently using one kind of antipsychotic drug at a dose that exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using two kinds of antipsychotic drugs, at least one of which reaches or exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using three kinds of antipsychotic drugs or more; * Refractory schizophrenia patient…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PANSS (positive and negative symptoms scale) total score

Timeframe: baseline,8 weeks

PANSS positive score

Timeframe: baseline,8 weeks

CGI-S (clinical general impression-severity)

Timeframe: baseline,8 weeks

Trial details

NCT IDNCT03289026

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-23

View on ClinicalTrials.gov More Acute Schizophrenia Episode trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.